Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients (My-Rept_KT_P4)

Open Label, Randomized, Multi-center, Phase 4 Trial to Evaluate the Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) Versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination With Tacrolimus for 26 Weeks in Kidney Transplant Patients

Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Mycophenolate Mofetil 500mg; Drug: Mycophenolate Mofetil 250mg

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Maryknoll Medical Center
  • Chonju, Korea, Republic of
    • Chunbuk National University Hospital
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Iksan, Korea, Republic of
    • Wonkwang University School of Medical & Hospital
  • Seongnam, Korea, Republic of
    • Bundang Cha Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Kandong Sacred Heart Hospital
  • Suwan, Korea, Republic of
    • Ajou University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 20 years or older.
2. Patient who receive primary or secondary kidney transplantation from living or brain-dead donor .
3. Patient who receive age 20 years or older donor.
4. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Cold Ischemia Time > 30 hours.
2. Patient who receive HLA-identical donor.
3. Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current.
4. Patient who receive extra-renal solid organ or bone marrow stem cell transplantation.
5. Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death
6. Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor.
7. Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma)
8. Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor.
9. Patient with Severe gastrointestinal disease in screening period by investigator's decision.
10. Patient with systemic severe infection requiring treatment (able to transplantation after completely disappear or is controlled infection)
11. Liver cirrhosis, clinically significant portal hypertension or other moderate to severe liver disease.

12. Defined by the following laboratory parameters before screening period

    1. One of liver function test(AST, ALT, ALP, Total Bilirubin)results increased more than 3 times upper limit of normal range
    2. WBC <2,500/mm3, Platelet <75,000/mm3
13. Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs (ex, mycophenolate acid or tacrolimus, etc.) or additives.
14. Administration of other Investigational drugs and/or immunosuppressants within 28days before screening period (except allowed immunosuppressants in protocol)
15. Women in pregnant or breast-feeding or don't using adequate contraception.
16. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
17. In investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: My-Rept® Tablet; My-Rept® Tablet, Mycophenolate Mofetil 500mg, orally	Drug: Mycophenolate Mofetil 500mg; Other Names: My-Rept® Tablet
Active Comparator: My-Rept® Capsule; My-Rept® Capsule, Mycophenolate Mofetil 250mg, orally	Drug: Mycophenolate Mofetil 250mg; Other Names: My-Rept® Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of efficacy failure	efficacy failure=acute rejection by kidney biopsy,graft loss, death	up to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute rejection by kidney biopsy		up to 26 weeks
Survival with no graft loss		up to 26 weeks
eGFR(using by MDRD method)		up to 26 weeks
Number of Participants with Adverse Events	Rate of adverse events; Evaluated safety parameters included: Physical examination, laboratory test, etc.	up to 26 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Yu Seun Kim, Ph. D, Severance Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: MMF; Mycophenolate Mofetil
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: 223KTP12003